Product code GJE— Clinical Chemistry

FDA has cleared 7 devices under product code GJE between 1976 and 1996, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19961 clearance
• 19941 clearance
• 19781 clearance
• 19773 clearances
• 19761 clearance

• Bd Becton Dickinson Vacutainer Systems Preanalytic3 clearances
• J.J. Skinner, Inc.1 clearance
• Customed, Inc.1 clearance
• Concord Laboratories, Inc.1 clearance
• Bio/Data Corp.1 clearance

• K962596 — CUSTOMED BLOOD EXTRACTION KITCustomed, Inc.·1996-09-27
• K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KITJ.J. Skinner, Inc.·1994-04-11
• K780303 — AUTO ISO-FILTER COLLECTION TUBE CAPBd Becton Dickinson Vacutainer Systems Preanalytic·1978-03-30
• K771489 — RTERIAL BLOOD SAMPLING KITBd Becton Dickinson Vacutainer Systems Preanalytic·1977-08-22
• K771370 — ICROTAINEO BRAND TUBEBd Becton Dickinson Vacutainer Systems Preanalytic·1977-08-03
• K761177 — SODIUM CITRATEBio/Data Corp.·1977-01-10
• K760086 — TRAY, BLOOD SAMPLING (PULSATOR II)Concord Laboratories, Inc.·1976-07-16